The present invention generally relates to tissue sealant compositions and vascular closure devices incorporating optical dyes for use in medical procedures and methods, for example, for monitoring and enhancing hemostatic sealing of non-suture arterial closure devices.
Blood loss is a concern for trauma and wound treatment and more generally during and after many medical procedures. An important goal is facilitating hemostasis (e.g., arrest of bleeding), by the physiological properties of vasoconstriction or coagulation and/or by surgical means. Conventional techniques to control bleeding and repair wounds include electrocautery, application of pressure, suturing, and stapling.
Millions of interventional diagnostic procedures are performed annually worldwide. As an example, several million coronary angiograms are performed for diagnostic or other purposes. See, e.g., Ruygrok et al., Catheterization and Cardiovascular Interventions 66, 185-91, (2005). Femoral artery puncture provides vascular access for such catheter procedures in the majority of patients. Following removal of the catheter device, hemostasis is commonly achieved by a period of manual compression and prolonged immobilization. This often involves specialized nursing units, and can be a strain on hospital resources. It may also be a source of inconvenience and discomfort for the patient.
A number of studies have shown that simple manual compression (e.g., with a sandbag or other external compression device) may result in complications at or near the puncture site (e.g. in the groin region). See, e.g., Gerkens et al., Am. J. Cardiol. 83(12), 1658-63, (1999). Serious complications may result, including arterial pseudoaneurysms (with rupture), arteriovenous fistulae, acute arterial occlusion, and/or infection.
Suture mediated and non-suture mediated compositions, devices, and methods to facilitate wound or puncture treatment and hemostasis have been developed and employed over the past twenty years. Hemostatic agents and tissue sealants, in general, operate to stop bleeding by mechanically closing defects in tissue and/or by augmenting the mammalian coagulation cascade. These compositions and/or devices may operate as a form of mechanical barrier, plug, or patch to close the vessel or other puncture site and/or may supplement the natural hemostatic process. A number of non-suture mediated compositions and devices are in use or in clinical trials in the United States. Collagen plugs are exemplary of these compositions and devices, and are applied and held in place by a variety of different mechanisms. See, e.g., Nygaard et al., Catheterization and Cardiovascular Interventions 52, 3-7, (2001). Failures and complications from such compositions and devices are generally minor and may occur, for example, by improper placement of the plug.
As will be generally recognized from the foregoing, a need currently exists for tissue sealants and closure devices for biomedical applications. Specifically, tissue sealants and closure devices are needed that provide enhanced functionality for wound or puncture treatment and for establishing and maintaining hemostasis.